Irinotecan in Combination With Fluorouracil in a 48-Hour Continuous Infusion As First-Line Chemotherapy for Elderly Patients With Metastatic Colorectal Cancer: A Spanish Cooperative Group for the Treatment of Digestive Tumors Study

Sastre, Javier; Marcuello, Eugenio; Masutti, B.; Navarro, Matilde; Gil, Silvia; Antón, Antonio; Abad, Albert; Aranda, Enrique; Maurel, Joan; Valladares, Manuel; Maestu, Inmaculada; Carrato, Alfredo; Vicent, J. M.; Dı́az-Rubio, Eduardo

doi:10.1200/jco.2005.03.004

Cited by 89 publications

(28 citation statements)

References 36 publications

(4 reference statements)

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“…Combination chemotherapy also appears to be beneficial in healthy older patients. Results of pooled analyses of both oxaliplatin-and irinotecan-based regimens have been found to be the same as those of FU trials (11)(12)(13). In contrast, in a smaller phase III trial that compared weekly versus every-third-week irinotecan, patients >70 years of age had significantly increased odds of suffering grade 3 or 4 diarrhea and neutropenia than younger patients (14).…”

Section: Introductionmentioning

confidence: 61%

Grade 3/4 neutropenia is a limiting factor in second-line FOLFIRI following FOLFOX4 failure in elderly patients with metastatic colorectal cancer

et al. 2011

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Abstract. Previous studies have reported improved outcomes for elderly patients with metastatic colorectal cancer (mCRC) treated with oxaliplatin or irinotecan as first-line chemotherapy. However, few studies regarding second-line chemotherapy with oxaliplatin or irinotecan are currenlty available. We analyzed retrospectively the efficacy and toxicity in elderly patients (median age, 74 years) treated with second-line FOLFIRI following first-line FOLFOX4 failure. From March 2005 to January 2008, 35 elderly patients with mCRC received firstline FOLFOX4 comprising leucovorin, 5-FU and oxaliplatin followed by second-line FOLFIRI comprising leucovorin, 5-FU and irinotecan. The median number of treatment courses with FOLFIRI was 5 (range 2-32). One patient responded to the treatment. The disease control rate was 38.2%. The median time to treatment failure was 3 months, and the median overall survival (OS) time from the beginning of first-line chemotherapy was 20.7 months. The incidence of grade 3/4 neutropenia was 71.4%, while febrile neutropenia was 11.4%. The incidence of non-hematological toxicity was low. The use of the three active drugs, 5-FU, oxaliplatin and irinotecan, in mCRC produced the longest OS in elderly as well as in younger patients. However, the elderly patients treated with second-line FOLFIRI had a high rate of hematological toxicity. Second-line FOLFIRI may therefore be used with caution in the elderly.

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Section: Introductionmentioning

confidence: 61%

Grade 3/4 neutropenia is a limiting factor in second-line FOLFIRI following FOLFOX4 failure in elderly patients with metastatic colorectal cancer

et al. 2011

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“…From a practical perspective, the CGA allows us to recognize three stages of aging: fit patients (functionally independent and without comorbidities), who are candidates for standard cancer treatment; patients who are frail (dependence in one or more activities of daily living, three or more comorbid conditions that may compromise survival, or one or more geriatric syndromes), who are candidates only for palliative treatment; and an intermediate group for whom pharmacological approaches such as dose reduction or any type of support should be considered [12]. Recent studies including combination therapy in fit elderly patients reported ORRs in the range of 35%-36% [13,14], which are consistent with pooled and subgroup analyses from elderly patients included in phase III trials, and suggest a benefit similar to that of younger patients treated with combination therapy [15][16][17][18]. Nevertheless, only a few patients aged Ն70 years can be considered fit after a CGA.…”

Section: Discussionmentioning

confidence: 99%

First-Line Cetuximab Plus Capecitabine in Elderly Patients with Advanced Colorectal Cancer: Clinical Outcome and Subgroup Analysis According toKRASStatus from a Spanish TTD Group Study

Sastre

Grávalos²,

Rivera

et al. 2012

The Oncologist

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Single-agent cetuximab is safe and active in elderly patients with advanced colorectal cancer (CRC). A cetuximab-capecitabine combination has not previously been tested in elderly patients with advanced CRC.Material and Methods. Sixty-six patients with advanced CRC were treated with cetuximab as a 400 mg/m 2 i.v. infusion followed by 250 mg/m 2 i.v. weekly plus capecitabine at a dose of 1,250 mg/m 2 every 12 hours. After the inclusion of 27 patients, the protocol was amended for safety reasons, reducing the dose of capecitabine to 1,000 mg/m 2 every 12 hours. Thirty-nine additional patients were treated with the reduced dose of capecitabine.Results. The overall response rate was 31.8%. KRAS status was determined in 58 patients (88%). Fourteen of 29 patients with wild-type KRAS tumors responded (48.3%; 95% confidence interval [CI], 29.4%-67.5%), compared with six of 29 patients with mutant KRAS tumors (20.7%; 95% CI, 8.0%-39.7%). The median progression-free survival (PFS) interval was 7.1 months. The median PFS interval for patients whose tumors were wild-type KRAS was significantly longer than for those with mutant KRAS tumors (8.4 months versus 6.0 months; p ‫؍‬ .024). The high incidence of severe paronychia (29.6%) declined (7.7%) after capecitabine dose adjustment.Conclusions. Cetuximab plus capecitabine at a dose of 1,000 mg/m 2 every 12 hours may be an alternative to more aggressive regimens in elderly patients with advanced wild-type KRAS CRC.

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“…Patients with mCRC who have a PS of 2 should be considered for chemotherapy, particularly if their PS decline is cancer related (Rosati et al, 2005). At the time of progression, patients initially treated with mono-chemotherapy and whose PS has improved could be treated with combination chemotherapy including irinotecan and oxaliplatin (Sastre et al, 2005;Arkenau et al, 2008). In our study, 41.7% of the patients were considered appropriate candidate for second-line treatment while 16.7% of the patients received third-line chemotherapy.…”

Section: Discussionmentioning

confidence: 73%

First-Line Mono-Chemotherapy in Frail Elderly Patients with Metastatic Colorectal Cancer

Varol

Dirican²,

Yıldız³

et al. 2014

Asian Pacific Journal of Cancer Prevention

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Background: Unlike for fit elderly metastatic colorectal cancer (mCRC) patients, general approaches to initial treatment for the frail older mCRC patients are not clear. Our aim was to evaluate the efficiency and safety of first-line single-agent treatment in one such group. Materials and Methods: We retrospectively evaluated mCRC patients aged 70 or older with an Eastern Cooperative Oncology Group performance score of 2. They had no prior treatment and underwent first-line single-agent capecitabine or other monotherapies until disease progression or unacceptable toxicity. Results: Thirty-six patients were included. Most (n:28, 77.8%) were treated with capecitabine. One patient achieved a complete response and 5 patients had a partial response for an overall response rate of 16.6%. Twelve patients (33.3%) remained stable. Median progression free survival was 5 months (confidence interval (CI), %; 3.59-6.40) and median overall survival was 10 months (95 CI%; 8.1-11.8). Grade 3-4 toxicity was found in 6 patients (16.6%). Febrile neutropenia was not observed and there were no toxicity-associated deaths. Conclusions: Capecitabine is a safe chemotherapeutic agent with moderate activity for first-line treatment of older metastatic colorectal cancer patients with limited performance status.

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Irinotecan in Combination With Fluorouracil in a 48-Hour Continuous Infusion As First-Line Chemotherapy for Elderly Patients With Metastatic Colorectal Cancer: A Spanish Cooperative Group for the Treatment of Digestive Tumors Study

Abstract: Twice a month continuous-infusion CPT-11 combined with FU is a valid therapeutic alternative for elderly patients in good general condition.

Cited by 89 publications

References 36 publications

Grade 3/4 neutropenia is a limiting factor in second-line FOLFIRI following FOLFOX4 failure in elderly patients with metastatic colorectal cancer

Grade 3/4 neutropenia is a limiting factor in second-line FOLFIRI following FOLFOX4 failure in elderly patients with metastatic colorectal cancer

First-Line Cetuximab Plus Capecitabine in Elderly Patients with Advanced Colorectal Cancer: Clinical Outcome and Subgroup Analysis According toKRASStatus from a Spanish TTD Group Study

First-Line Mono-Chemotherapy in Frail Elderly Patients with Metastatic Colorectal Cancer

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